Can-Fite Receives from Gebro Holdings $2,200,000 Payment as Part of Distribution Agreement for Piclidenoson in 3 European Countries

Source:  Can-Fite BioPharma Ltd.

Additional milestone payments of up to $7,000,000 and double digit royalty payments on net sales upon the achievement of certain regulatory, launch and sales milestones

 

Recently signed Gebro distribution agreement adds to the two existing distribution agreements for Piclidenoson in Canada and Korea

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced it has received its first payment of approximately $2,200,000 from Gebro Holdings GmbH. Can-Fite recently announced entering into a distribution agreement with Gebro for the exclusive right to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of rheumatoid arthritis and psoriasis in 3 European countries including Spain, Switzerland and Austria, upon receipt of regulatory approvals. The recently signed Gebro distribution agreement adds to the distribution agreements for Piclidenoson that the company already has in place with Cipher Pharmaceuticals (for the distribution of Piclidenoson in Canada for rheumatoid arthritis and psoriasis) and Kwang Dong Pharmaceutical (for the distribution of Piclidenoson in Korea for rheumatoid arthritis).  

Under the terms of the distribution agreement, Gebro is making a total upfront and milestone payment of approximately $2,200,000 to Can-Fite. In addition, the agreement provides that additional payments of up to approximately $7,000,000 will be received by Can-Fite upon the achievement of certain regulatory, launch and sales milestones plus double digit royalty payments on net sales.

Gebro Pharma is a privately-owned leading pharma group founded in Austria in the late 1940s with over 500 employees. Its headquarters are located in Fieberbrunn (Austria), where Gebro is a top local leading player, with commercial operations in Spain and Switzerland. In Spain, Gebro is ranked among the top growing companies within the Pharma sector. The therapeutic focus of Gebro is pain with a strong franchise in rheumatology and in Spain, Gebro is ranked nº1 in rheumatology and pain. Alongside, rheumatology and pain, Gebro has also built a portfolio around dermatology, urology, respiratory, GI, and CV depending on the territory.

“We are pleased to receive this upfront and milestone payment of $2,200,000 from Gebro and look towards future potential milestone payments as we advance Piclidenoson through completion of our current Phase III trials in rheumatoid arthritis and psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman. Can-Fite recently initiated patient enrollment for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis.

The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis during 2018. Can-Fite’s liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Can-Fite 12 Months' Activities & Milestones for 2018

Source:  Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced its near-term milestones for 2018, including events related to the rheumatoid arthritis/psoriasis drug Piclidenoson and the liver disease drug Namodenoson.

The Company believes that it is close to reaching certain significant clinical milestones in its efforts to bring the two lead drug candidates, Piclidenoson and Namodenoson, to market. Both drug candidates are administered to patients orally in the form of a tablet and have demonstrated an excellent safety profile in prior clinical trials. The below near-term key events provide an outlook of Can-Fite's objectives and potential for increased growth.
Piclidenoson

• A pivotal Phase III study, ACRobat®, for the treatment of patients with rheumatoid arthritis is currently enrolling patients to evaluate the drug as a first line treatment and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis.
• A pivotal Phase III study, Comfort®, for the treatment of patients with moderate-to-severe plaque psoriasis in comparison to placebo and as compared to apremilast (Otezla®) is expected to commence during 2018.
  
  Can-Fite expects that these pivotal Phase III studies will serve as the first of two pivotal studies required for European Medicines Agency (EMA) drug approval.

Namodenoson

• Top-line results from the ongoing Phase II study with Namodenoson for patients with advanced liver cancer is expected in the second half of 2018. Enrollment of all 78 subjects in Israel, Europe and the U.S. has been completed and the Company continues to follow up on patients’ overall survival.
• Phase II study in patients with NAFLD/NASH has commenced in Israel, and is expected to enroll approximately 60 patients. The Company aims to complete enrollment for this study in the next twelve months.

Biomarker

• The Company has already developed a high throughput screening assay which is conducted in a central lab for the evaluation of the A3AR Biomarker in a small blood sample withdrawn from the patients in each of the trials. The purpose of analyzing the biomarker prior to treatment is to help identify an individual patient's responsiveness to the Company's drugs, providing more personalized medicine. In case a direct correlation between biomarker level prior to treatment and patients’ response to the drug is demonstrated, the Company expects this to have additional commercial applications. The U.S. Patent and Trademark Office previously issued a patent for the utilization of A3AR as a biomarker to predict patient response to Piclidenoson in autoimmune inflammatory indications.

“We are very excited at the opportunity of potentially receiving further validation of our drug candidates, which represents significant steps forward in our commitment to delivering treatments to patients. We hope to see this come to fruition upon conclusion of our various trials,” stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite's Piclidenoson and Namodenoson are focused on multibillion-dollar market opportunities. The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet-need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis during 2018. Can-Fite’s liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Can-Fite Signs Multi-Million Dollar Distribution Agreement for Piclidenoson in 3 European Countries with Gebro Holdings

Source:  Can-Fite BioPharma Ltd.

Agreement includes upfront and milestone payments, plus royalties

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced it has signed a distribution agreement with Gebro Holding GmBH to distribute Can-Fite’s lead drug candidate, Piclidenoson (CF101), for the treatment of rheumatoid arthritis and psoriasis in 3 European countries including Spain, Switzerland and Austria, upon receipt of regulatory approvals. 

Under the terms of the distribution agreement, Gebro is making a total upfront and milestone payment of approximately $2,000,000 to Can-Fite. In addition, the agreement provides that additional payments of up to approximately $7,000,000 will be received by Can-Fite upon the achievement of certain regulatory, launch and sales milestones plus double-digit percentage royalty payments on net sales.

Gebro Pharma is a privately-owned leading pharma group founded in Austria in the late 1940s with over 500 employees. Its headquarters are located in Fieberbrunn (Austria), where Gebro is a top local leading player, with commercial operations in Spain and Switzerland. In Spain, Gebro is ranked among the top growing companies within the Pharma sector. The therapeutic focus of Gebro is pain with a strong franchise in rheumatology and in Spain, Gebro is ranked nº1 in rheumatology and pain. Alongside, rheumatology and pain, Gebro has also built a portfolio around dermatology, urology, respiratory, GI, and CV depending on the territory.

“We are very excited to enter into this agreement with Gebro and believe that they are the right partner for us to penetrate the European market,” stated Sari Fishman, VP Business Development of Can-Fite. “We believe that Gebro’s commitment to us is a strong validation of our development efforts to date.”

Can-Fite recently initiated patient enrolment for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis.

The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

Upon receipt of payments due at signing of the agreement, the Company believes that its shareholders’ equity is above $4.0 million.

About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in early 2018. Can-Fite’s liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Can-Fite Enters into Collaborative Research Agreement with Hadassah Medical Center to Further Explore Namodenoson Mechanism of Action in NASH

Source:  Can-Fite BioPharma Ltd.

• Namodenoson improves steatosis, inflammation and ballooning in pre-clinical studies
• A Phase II study of Namodenoson is enrolling NAFLD/NASH patients

 

 

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced the entry into a collaborative research agreement with Hadassah Medical School. This agreement will support research directed by Rifaat Safadi, M.D. aimed at further elucidating the Namodenoson mechanism of action in experimental models of non-alcoholic steatohepatitis (NASH) which represent the human disease.

 

Recent pre-clinical studies with Namodenoson showed an improvement in three cardinal NASH parameters including steatosis, inflammation and ballooning, which collectively define the histopathologic NAS (non-alcoholic fatty liver disease [NAFLD] Activity Score). The data, summarized in the accompanying graph, demonstrate a significant anti-NASH effect and represent the basis for the collaborative research program with Dr. Safadi.

Dr. Safadi is the Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center and Professor of Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at Hadassah University in Israel. He is a prolific researcher and a highly respected thought leader in the field of NASH. Dr. Safadi’s areas of expertise include liver and bowel diseases, and the metabolic syndrome. He has published widely in high-impact journals and is also a member of Can-Fite’s Clinical Advisory Board.

“Can-Fite’s Namodenoson drug is unique among today’s NASH drugs under development due to its excellent safety profile and the positive effect on steatosis, inflammation and fibrosis. We are very happy to initiate this collaboration,” said Dr. Safadi.

Lately Can-Fite initiated patient enrollment for a Phase II study with Namodenoson in NAFLD/NASH patients with evidence of active inflammation. Based on the recent pre-clinical data, the company has changed the primary end point of the Phase II study to the anti-inflammatory effect of the drug, as determined by blood ALT levels, and changed the major secondary end point to % of liver fat, measured by PDFF (proton density fat fraction). The Company believes this amendment sets the stage to increase the chances of trial success by aligning the clinical outcomes with the drug’s mechanism of action.

“We are privileged to work with Dr. Safadi to further study and advance the drug’s mechanism of action,” said Pnina Fishman, Ph.D., Founder and Chief Executive Officer of Can-Fite.

About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in early 2018. Can-Fite’s liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.
 

 

Can-Fite Reports on the Progress of Its Phase II Liver Cancer with Namodenoson

 

Source: Can-Fite BioPharma Ltd.

• Accumulated safety data to date indicate potential favorable drug safety profile without hepatotoxicity
• Company anticipates data release to occur in 2H2018

Can-Fite BioPharma Ltd. (NYSEAM:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today provided an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC). Ongoing close observation of enrolled subjects indicates a potentially favorable drug safety profile. The Company previously announced in August that it had successfully completed enrollment of 78 patients.

The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Although the trial remains blinded to the Company, accumulated safety data to date indicate a potentially favorable drug safety profile without hepatotoxicity and possible positive clinical effects. There are now subjects treated for more than one year and in some cases, two years. To date, 15 subjects have completed at least 12 cycles of treatment (each cycle is 28 days of treatment) of which two completed 24 cycles. The Company anticipates data release to occur in 2H2018.
Can-Fite CEO Dr. Pnina Fishman commented, “We are pleased with the progress so far in our clinical trial for Namodenoson for the treatment of advanced HCC, the third leading cause of cancer deaths worldwide, and look forward to data release later in 2018.”

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.
 
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.
 
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSEAM:CANF) (TASE:CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multibillion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in early 2018. Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers, including colon, prostate and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies, and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile, with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Johnson & Johnson Veteran Chuck Austin To Scale Up BioSig Operations

Source:  BioSig Technologies, Inc.


BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that it has partnered with Mr. Charles (Chuck) Austin and JK Advisors in order to scale up operational activities ahead of the commercial launch of PURE EP(tm) System.

Mr. Austin brings to the Company over 25 years of experience in medical devices, pharmaceuticals and consumer products. Most recently, he served as Corporate Vice President, Global Supply Chain at Johnson & Johnson, and was a member of the J&J Management Committee. In this role, he was responsible for over 60,000 associates at 130 sites around the world while overseeing over 500 external manufacturers, over $22BB in direct spend, and supported in excess of $70BB in sales. His leadership positions within Johnson & Johnson included Company Group Chairman for Ethicon Surgical Care and Worldwide President for Ethicon Endo-Surgery.

The appointment of Mr. Austin comes at a crucial time for BioSig, as the Company executes its market entry in the U.S. in 2018.

Mr. Austin currently serves on multiple boards in the medical and consumer spaces and is a Principal in JK Advisors, a San Diego based firm focused on the medical space. 

“BioSig has impressed us with a strong value proposition and support of leading centers of excellence in the industry. I’m delighted to join the BioSig team at this important time and contribute my knowledge to take the Company to the next level,” commented Mr. Austin.

“BioSig is excited to be working with an executive leader like Chuck. His 25 plus years of experience working for one of the world's leading healthcare organizations can significantly benefit our effort to launch and expand our business operations,” stated Mr. Kenneth Londoner, Chairman & CEO of BioSig Technologies, Inc. “While we expect Chuck to make his initial impact on manufacturing, logistics, and operations, his experience in successfully deploying new commercial models and driving global growth in the medical device marketplace will create value for all our stakeholders. This is an excellent way to kick off our efforts in 2018, which promises to be a pivotal year for the Company.”

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

BIOSIG TECHNOLOGIES COMPLETES PRIVATE PLACEMENT

Source:  BioSig Technologies, Inc.

Capital Raised To Support Operational Growth Ahead of Commercial Launch

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company closed a private placement with proceeds of $4,512,901. 

The Company issued 3,008,607 common shares at a price of $1.50 per share and a half warrant with a 3-year expiration at a cash exercise price of $1.50.

“The continued ability to raise quality capital from long-term shareholders, who build the foundation of our shareholder base, allow us to advance our efforts towards targeted commercial launch later this year,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

 

BioSig Technologies Appoints New Chief Financial Officer to Facilitate Growth Trajectory

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that Mr. Steven (Steve) Chaussy will be joining the company to serve in the role of Chief Financial Officer.

Mr. Chaussy brings over 30 years of financial and operating experience to the Company. Prior to joining BioSig Technologies, Mr. Chaussy has been the sole proprietor of Anna & Co., Inc., a consulting company that offers financial and accounting services to small publicly traded companies. Mr. Chaussy has an extensive entrepreneurial growth and development background learned from working for Penske Truck Leasing Co., L.P., a subsidiary of Penske Corporation, where his improvements of management and reporting tools have allowed the company to double in size. During his career, Mr. Chaussy also served as Chief Financial Officer to a number of private and public companies. The systems introduced by Mr. Chaussy have been key drivers of profitability and development of international business lines. Mr. Chaussy is a CPA and received his degree in Accounting from Virginia Polytechnic Institute and State University.

In his role as CFO, Mr Chaussy will be responsible for ensuring the financial organization required to support the Company’s aggressive growth strategy while establishing a strong foundation for long-term progress.

"Steve has been supporting BioSig from the very beginning of our journey. As we step up our efforts towards commercialization, we needed a highly experienced, full-time CFO with the strong expertise in supporting emerging growth companies and successfully managing rapidly developing environments,” stated Mr. Kenneth Londoner, Chairman & CEO of BioSig Technologies, Inc.  “Steve’s ability to navigate complex markets is a definite value-add in both our pre-commercial activities and future growth of our organization.”

“I am both honored and excited to be joining the BioSig team at such a key point in their trajectory,” said Steven Chaussy. “I am impressed with the company current assets, management team and near-term commercialization prospects. I look forward to contributing to the future success of the Company.”

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

BioSig Technologies Issues Shareholder Letter for 2017

Source:  BioSig Technologies, Inc.

Highlights Improvements to Cap Structure, Commercial Relationships and Projected Milestones

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has officially issued a letter to its shareholders providing them with updates on recent operational developments, industry trends, and strategic business prospects.

Recent Company Highlights

• Solidified a 10-year collaboration deal with Mayo Clinic
• Completed a 2-year product assessment study with Health Research International, which has shown strong interest in evaluating PURE EP(tm) System and the ongoing need for innovation in the field of cardiac rhythm management
• Expanded shareholder base to 22 countries, including Switzerland, UK, Ireland, France, Spain, Israel, Qatar, UAE (Abu Dhabi/Dubai), Iceland, and others
• Appointed a number of strategic hires ahead of FDA 510(k) submission and targeted commercialization
• Signed a partnership agreement with one of the top IP strategy firms – Sherpa Technology Group
• Added Andrew Filler to the Board of Directors, who brings over 20 years of experience in intellectual property for technology and medical device companies
• Raised $ 5.5 million in equity at a premium-to-market.

“With so much positive news and industry activity, Management felt it was an ideal time to directly communicate with our loyal shareholder base,” stated Mr. Kenneth Londoner, Founder, Chairman and CEO of BioSig Technologies. “We believe that we have made significant strides to our company, both from a technological standpoint and through the addition of human capital.  Additionally, BioSig has significantly improved its financial standing while bolstering strategic industry relationships.  We remain confident in the capabilities of our innovative PURE EP™ System and our ability to successfully commercialize it within the multi-billion-dollar global electrophysiology market. We believe that our recent accomplishments will allow us to begin targeted commercialization and uplist to a more senior exchange in the near future, as we remain focused on our primary goal of enhancing shareholder value.”

To view BioSig Technologies’ Shareholder Letter please visit: link to Shareholder Letter

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP™ System.

BioSig Technologies Adds Role of Chief Regulatory and Compliance Officer in Preparation for FDA Submission

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has engaged Tiffini Wittwer as Chief Regulatory and Compliance Officer for the upcoming regulatory clearance of PURE EP(TM) System. 

Mrs. Wittwer brings to BioSig over 15 years of experience in FDA regulatory affairs on behalf of public and private companies, most notably Trice Medical, Inc., Embrella Cardiovascular, Inc. (acquired by Edwards Lifesciences in 2011) and Cardica, Inc. During her career, Mrs. Wittwer has successfully delivered FDA 510(k) clearance of mi-eye(TM) and mi-eye 2(TM) visualization systems for Trice Medical and CE mark for Embrella Cardiovascular’s Embolic Deflector system for the use during transcatheter heart valve procedures. In 2016, the sales of transcatheter heart valves represented 55% of all net sales of Edwards Lifesciences.

 “I am pleased to join BioSig during this important time in preparation for FDA 510(k) submission for the PURE EP System. Commercialization is fully dependent on the success of the steps leading to the regulatory clearance. I look forward to contributing my knowledge and expertise to ensure a timely submission of the Company’s 510(k) application with FDA,” commented Mrs. Wittwer.

“Tiffini has been recommended to us for her outstanding work with getting FDA approvals for cardiac medical devices. Her track record in successfully delivering regulatory clearances on both sides of the Atlantic is of significant value to the future commercialization of our technology both in the US and in Europe. We remain fully on track for the targeted launch of our commercial efforts in the second half of 2018,” said Kenneth Londoner, Chairman & Chief Executive Officer of BioSig Technologies, Inc.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The Company’s first product, PURE EP(TM) System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

BioSig Technologies Partners with Sherpa Technology Group

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has hired Sherpa Technology Group as its Intellectual Property Advisor.

Sherpa Technology Group (STG), formerly known as 3LP Advisors, is a leading Silicon Valley IP advisory firm that assists clients at the intersection of business, technology, and intellectual property. Established in 2008 by a small group of IP strategy veterans, STG has been providing intellectual property and technology strategy support, including partnership analysis, IP portfolio development, licensing, and monetization strategy support to a number of high profile Silicon Valley firms.

“We are very pleased to guide BioSig through their IP strategy at this important time in the Company’s development, and we look forward to exploring the opportunities for wider applications of BioSig’s technology,” commented Kevin Rivette(1), Managing Partner of Sherpa Technology Group, former Vice President at IBM Corporation, and former Senior Advisor to The Boston Consulting Group.

“Over the past six months we engaged with BioSig’s Board and management, as well as independently interacted with some of the Company’s strategic partners. We are very optimistic about BioSig’s future as a technology company with cutting-edge signal processing hardware and software,” added Andrew Filler(2), Partner and General Counsel of Sherpa Technology Group.

“As BioSig advances toward commercialization, we needed a world-class partner to build a solid IP strategy that will allow us to apply our technology to the new field of bioelectronic medicine. The impact that Kevin and the rest of the STG team(3) had on the IP strategies for some of the most well-known tech companies in the world was unmatched. Their ability to marry IP strategy with the establishment of sustainable and profitable business models was an ideal fit with our thinking and needs. Forging a long-term strategic relationship with STG will cement our intellectual property portfolio as a leader in the field,” said Kenneth Londoner, Chairman & Chief Executive Officer of BioSig Technologies, Inc.

(1) Kevin Rivette is the former Chairman of the USPTO oversight committee. In 2008, Kevin was named to the IP Hall of Fame by IAM magazine. In 2009 he was named one of “The World’s Leading IP Strategists”.
(2) Andrew Filler was named as one of the top two corporate IP attorneys in Silicon Valley by the San Jose/Silicon Valley Business Journal in 2011.
(3) Other key members include: Ralph Eckardt, Managing Partner, was named as one of “The World’s Leading IP Strategists” by IAM magazine; Peter Detkin, Senior Advisor, was named as the second most influential “IP market maker” in the world by IAM.

About Sherpa Technology Group
Founded in 2008 as 3LP Advisors, Sherpa Technology Group is a strategy and M&A advisor on technology and intellectual property ("IP") matters. The firm's clients range from Fortune 500 companies, to emerging technology companies, to investors and investment banks.
Sherpa Technology Group has world-class experience in IP strategy, management consulting, investment banking, and engineering. Members of its leadership team formerly ran The Boston Consulting Group's IP Strategy Practice and were responsible for authoring prominent books on IP strategy, including Rembrandts in the Attic (2000) and The Invisible Edge (2009). Sherpa Technology Group's team comprises IP pioneers who managed and monetized leading patent estates for the world's most recognizable companies, such as IBM Corporation, Intel Corporation, and Intellectual Ventures. The firm has offices in Silicon Valley and Boston.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary technology platform designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.
The PURE EP System is a novel cardiac signal acquisition and display system, which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

IP veteran Andrew Filler joins BioSig Technologies’ Board of Directors

Source:  BioSig Technologies, Inc.

BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced the appointment of Andrew Filler to the Company’s Board of Directors. 

Mr. Filler brings to BioSig over 20 years of experience in intellectual property for technology and medical device companies. He currently serves as Partner and General Counsel for Sherpa Technology Group, a leading Silicon Valley IP advisory firm. Prior to this assignment, Mr. Filler served as Vice President of IP for Nanosys, Inc., where he created and managed one of the largest nanotechnology patent portfolios in the world with over 800 patents and applications. Under his leadership Nanosys completed hundreds of multi-million-dollar licensing, equity and collaborative agreements with companies such as Samsung, Intel, LG and Medtronic.  Mr. Filler was recently named as one of the top two corporate IP attorneys in Silicon Valley by the San Jose/Silicon Valley Business Journal in 2011 and previously served as chief intellectual property counsel at Caliper Technologies, senior associate attorney at Weil, Gotshal & Manges, and director of intellectual property at Corvascular.

Mr. Filler will be taking the seat of Dr. Jerome B. Zeldis, former Chief Executive Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation, who has faithfully served the BioSig shareholders since 2014 and is now retiring from Board service.
 
“The quality of our Board of Directors is our biggest asset. The guidance that each Board member has brought to the Company throughout the years was, and remains, invaluable. As we progress towards commercialization, Andy’s deep understanding of technology and his impressive legal background will be key components for shaping our future licensing and business development strategy,” said Kenneth Londoner, Chairman and Chief Executive Officer of BioSig Technologies, Inc.

About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System.  The technology has been developed to address an unmet need in a large and growing market.

The PURE EP System is a novel cardiac signal acquisition and display system, which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.

HelloGbye Launches in Apple App Store

Source:  HelloGbye

HelloGbye announced its new, game-changing travel app is now available for iPhone at the Apple App Store, or by visiting www.hellogbye.com on desktop or tablet.

HelloGbye makes booking any combination of flight and hotel itineraries extremely simple and fast for small businesses, frequent fliers, luxury travelers and groups.

HelloGbye enhances the search and booking process by eliminating the restrictive forms and fields that plague existing online travel providers. Instead, the platform offers a rich, user-friendly real-time conversational experience that allows users to search and book multi-city, multi-passenger trips in seconds by using their voice or typing.

“HelloGbye’s new groundbreaking search and scheduling technology dramatically simplifies the booking experience for travelers who do not have hours to waste with complicated online travel services. Unlike the traditional, time-consuming methods largely available online today, HelloGbye’s users can book intricate travel itineraries best suited to them, faster than ever before. With HelloGbye, users can spend less time planning and more time traveling,” said Jonathan Miller, founder of HelloGbye.

While some other services rely on call center agents, HelloGbye has fully digitized and personalized the search and booking process and is available 24/7/365. And in an industry first, HelloGbye has simplified post-booking changes, allowing users to change booked flights and hotels within the platform at any time without people.

HelloGbye is also excited that its service integrates one of the most advanced hotel search and booking selection tools in the travel industry, in partnership with American Express. This capability now offers the best hotel selection to each user for each itinerary, every time harnessing American Express’ advanced analytics.

In addition to a free option, HelloGbye’s subscription model unlocks access to a slate of must-have features. For a low monthly fee, HelloGbye subscription member users enjoy no change fees, 2 percent cash back on hotels and preferred hotel rates.

About HelloGbye
HelloGbye is a breakthrough end-to-end digital travel company, providing users with a mobile and online desktop travel experience for search, booking and managing itineraries. Learn more at www.hellogbye.com and connect with us on www.facebook.com/hellogbyeinc, www.linkedin.com/company/hellogbye, www.twitter.com/hellogbye and YouTube.

New Travel Solution HelloGbye Partners with American Express

Source:  HelloGbye-November 16, 2016

HelloGbye App Now Available for Download Online

HelloGbye, LLC today announced a multi-phased partnership with American Express to offer an innovative and transformative approach to booking travel. Featuring a customer-friendly experience that uses simple voice or typed commands to book flights and hotels, the HelloGbye app is now available for download at www.hellogbye.com and will be available in the App Store in January. 

According to Jonathan Miller, HelloGbye founder, “Our new partnership will provide access to American Express’ data insights, capabilities and deep travel industry knowledge, allowing us to better tailor our offering for even the most demanding travelers. American Express’ success with using big data to create consumer insights helps our already intuitive technology offer even more customized itineraries to travelers.”

The HelloGbye platform uses sentient artificial intelligence that understands what consumers are saying when speaking to the app to individualize their travel preferences, intentions and itinerary faster and better than other existing platforms.

“Our partnership with HelloGbye is an example of how American Express’ big data analytics can bring unique predictive modeling capabilities to solve complex problems, such as hotel bookings, and help more travelers,” said Marc Ginsberg, vice president, Performance Marketing & Data Products, American Express. “As more of us book travel on our mobile devices, quickly viewing itineraries that are most relevant to our personal travel style is essential to any search. HelloGbye’s technology combined with Amex’s data insights delivers uniquely tailored results that make the mobile booking process quick and seamless.”

The HelloGbye app gives travelers the ability to book or make changes to flights and/or hotels without multiple drop down menus, filtering, and scrolling. Travelers can also plan for up to eight travelers in an itinerary, an industry first.

“We have worked with the American Express team to enhance our digital platform across iOS devices and online,” said Dr. James Valverde, HelloGbye Chief Analytics Officer. “We see huge potential for this partnership to help make our brand increasingly customized and tailored for the customer.”

The HelloGbye app is a free download and set-up is fast and easy. For details on booking fees and terms of use, customers can visit the app and website.

About HelloGbye
HelloGbye is a breakthrough end-to-end digital travel company, providing users with a mobile and online desktop travel experience for search, booking and managing itineraries. Learn more at hellogbye.com and connect with us on facebook.com/hellogbyeinc, linkedin.com/company/hellogbye, twitter.com/hellogbye, and YouTube.

About American Express
American Express is a global services company, providing customers with access to products, insights and experiences that enrich lives and build business success. Learn more at americanexpress.com and connect with us on facebook.com/americanexpress, foursquare.com/americanexpress, linkedin.com/company/american-express, twitter.com/americanexpress, and youtube.com/americanexpress.